UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer (UAB0718)

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00570232

UAB 0718 (Other Identifier)

F070824015

Details and patient eligibility

About

The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.

Full description

An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
3. Prior radiation therapy for head and neck cancer
4. Disease must be considered surgically resectable or candidate for curative reirradiation
5. Adequate diagnostic workup
6. Zubrod Performance Status 0-2
7. Life expectancy 12 weeks
8. Age 19, 9. Adequate laboratory data.

Exclusion criteria

1. Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
2. Patients who are pregnant or lactating
3. Psychological condition that renders the patient unable to understand the informed consent
4. Any situation or condition that will interfere with adherence to study activities.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Tarceva

Other group

Description:

All patients will be prescribed erlotinib 150mg daily

Treatment:

Drug: Erlotinib